NCT07044336 · AstraZeneca
Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)
What this study is about
This is a Phase III, 2-treatment group$1, randomly assigned, open label, conducted at multiple hospitals, global study assessing the effectiveness and safety of puxitatug samrotecan compared to physician's choice of chemotherapy (doxorubicin or paclitaxel) in participants with B7-H4 selected advanced/metastatic EC that progressed following platinum based chemotherapy and anti-PD-1/anti-PD-L1 therapy.
View original scientific description
This is a Phase III, 2-arm, randomized, open label, multicenter, global study assessing the efficacy and safety of puxitatug samrotecan compared to physician's choice of chemotherapy (doxorubicin or paclitaxel) in participants with B7-H4 selected advanced/metastatic EC that progressed following platinum based chemotherapy and anti-PD-1/anti-PD-L1 therapy.
Interventions
DRUG
Puxitatug Samrotecan
2.4 mg/kg on Day 1 Q3W Route of administration: IV infusion
DRUG
Doxorubicin
60 mg/m2 on Day 1 Q3W Route of administration: IV
DRUG
Paclitaxel
80 mg/m2 on Days 1, 8, and 15 in 28-day cycle Route of Administration: IV
Primary outcome measures
Progression Free Survival (PFS) for Arm A vs Arm B
Time frame: Approximately 3 years
PFS is defined as the time from randomization until progression per RECIST 1.1 as assessed by BICR or death due to any cause.
Overall survival (OS) for Arm A vs Arm B
Time frame: Approximately 3 years
OS is defined as the time from randomization until the date of death due to any cause.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- include but are not limited to the following:
- Histologically confirmed diagnosis of endometrial carcinoma or carcinosarcoma.
- Recurrent/metastatic EC ie, with radiological or objective evidence of recurrence or progression.
- Has received prior platinum-based chemotherapy and anti-programmed cell death 1 protein (PD-1)/anti- programmed cell death ligand 1 (PD-L1) therapy, either separately or in combination.
- A WHO/ECOG performance status of 0 or 1 at Screening.
- Has radiographically measurable disease by RECIST 1.1 The main
Exclusion criteria
- include but are not limited to the following:
- Had uterine sarcomas or uterine neuroendocrine carcinoma.
- Has had a recurrence of endometrial carcinoma or carcinosarcoma more than \> 12 months after completing platinum-based therapy administered in the curative-intent setting without any additional platinum-based therapy received in the recurrent setting.
- Had previously received treatment with any therapy (
Where
- Tucson, Arizona
- La Jolla, California
- Los Angeles, California
- Orange, California
- Washington D.C., District of Columbia
- Jupiter, Florida
- Miami, Florida
- Miami Beach, Florida
- New Port Richey, Florida
- Orlando, Florida
- Tampa, Florida
- West Palm Beach, Florida
And 50 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 10, 2026 · Source of record for eligibility and locations